Medical devices that incorporate ancillary substances

When a medical device incorporates an ancillary substance that could be classified as a medicinal product if used separately, specific regulatory consequences come into play under the MDR. Such devices typically fall under a higher classification as per Rule 14 and must be subjected to a mandatory consultation procedure outlined in Annex IX, Section 5.2 of the MDR. Notified bodies responsible for conformity assessments are required to consult with competent authorities to assess the quality and safety of medicinal substance incorporated into the medical device. The European Medicines Agency (EMA) serves as the Competent Authority for substances derived from human blood or plasma, or those under the centralized procedure. Manufacturers are responsible for preparing comprehensive information on the substance, formatted in the Common Technical Document (CTD), for this consultation procedure to verify the quality, safety, and usefulness of the substance.

To determine whether a substance has an ancillary action to that of the device, it's crucial to consider the quantity available to the human body or its constituents. If the manufacturer demonstrates that the substance exists in such a quantity that it does not impact the human body or its constituents, it is considered not to have an ancillary action to the device. Examples of substances that, if used separately, could be classified as medicinal products and may be available to the human body or its constituents, yet do not have an ancillary action to the device due to their limited quantity, include flavorings, colorants, antioxidants, or chelating agents. If the manufacturer confirms that the substance lacks any ancillary action to the device, they are prohibited from making claims about the benefits of that substance on the device's labeling, packaging, advertising, websites, or any other form of communication.

No, there is no requirement that an ancillary substance included in a medical device must be registered as a separate medicinal product. However, the quality, safety, and usefulness of the ancillary substance must be verified by a competent authority, following methods specified in Annex I of Directive 2001/83/EC. It's important to note that certain types of substances defined under Article 1(3) of Directive 2001/83/EC are explicitly excluded from the scope of the MDR under Article 1(6). For example, viable biological material or viable organisms used to achieve or support the specific medical purpose of the product are not regulated as medical devices.